Russian Kogenate Pediatric Study

Bayer

Status and phase: Completed; Phase 4

Conditions: Hemophilia A

Treatments: Drug: rFVIII-FS (Kogenate FS, BAY14-2222) 75 IU/kg, dosing three times per week (3 x 25 IU/kg); Drug: rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg twice per week (30 IU/kg + 40 IU/kg); Drug: rFVIII-FS (Kogenate FS, BAY14-2222) 70 IU/kg, dosing once per week

Study type: Interventional

Funder types: Industry

Identifiers

NCT00632814

12684

2014-005253-39 (EudraCT Number)

Details and patient eligibility

About

A prospective study to evaluate the effect of rFVIII-FS in different prophylactic regimens on bleeding events frequency and development of arthropathy in Previously Treated and Minimally treated Hemophilia A pediatric population.

Enrollment: 32 patients

Sex: Male

Ages: 1 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male
• Severe hemophilia A or moderate hemophilia A
• 1-12 years of age
• Requiring treatment with FVIII

Exclusion criteria

• Current or prior inhibitor or familial antecedents of inhibitor
• Surgery required during the study (9 months)
• Positive for HIV

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 3 patient groups

rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw

Experimental group

Description:

rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 70 IU/kg, dosing by injection once per week \[qw\] (weekly on Day 7 + 1 after previous injection) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)

Treatment:

Drug: rFVIII-FS (Kogenate FS, BAY14-2222) 70 IU/kg, dosing once per week

rFVIII-FS (Kogenate FS, BAY14-2222), biw (30 IU/kg + 40 IU/kg)

Experimental group

Description:

rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 70 IU/kg, dosing by injection twice per week \[biw\] (30 IU/kg \[day 1\] + 40 IU/kg \[day 4\]) for 9 months. Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)

Treatment:

Drug: rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg twice per week (30 IU/kg + 40 IU/kg)

rFVIII-FS (Kogenate FS, BAY14-2222), tiw (3 x 25 IU/kg)

Experimental group

Description:

rFVIII-FS (Octocog-alfa, antihemophilic factor \[recombinant\]) 75 IU/kg, dosing by injection three times per week \[tiw\] (3 x 25 IU/kg \[day 1, 3, 5\]) for 9 months. No escalation opportunity for participants in this group

Treatment:

Drug: rFVIII-FS (Kogenate FS, BAY14-2222) 75 IU/kg, dosing three times per week (3 x 25 IU/kg)